Austrian Multivessel Taxus-Stent Registry (AUTAX)

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00738686
First received: August 19, 2008
Last updated: August 20, 2008
Last verified: August 2008

August 19, 2008
August 20, 2008
June 2004
May 2008   (final data collection date for primary outcome measure)
Incidence of MACCE, defined as all-cause death, nonfatal acute myocardial infarction (AMI) target vessel revascularization (TVR) and cerebrovascular event during the two-year clinical follow-up (FUP) [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00738686 on ClinicalTrials.gov Archive Site
  • Break-down primary endpoints at the 2-year FUP, as the rate of TVR, non-fatal AMI, all-cause death, stroke and the composite of death and AMI [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Incidence of 30-days, 6-mo and 1-year MACCE [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute, subacute and late thrombosis rates [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Angiographic end-points as the binary restenosis rate per lesion (defined as diameters stenosis ≥ 50%), in-stent and proximal and distal in-lesion late lumen loss [ Time Frame: 6-month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Austrian Multivessel Taxus-Stent Registry
Austrian Multivessel Taxus-Stent Registry

The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel disease and multiple Taxus stent implantations in the "real world" stenting at 30 days, 6 and 12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to economic considerations, the secondary aim is to enhance experience in multivessel stenting with drug-eluting stents in order to improve short- and long-term outcomes of the patients with severe multiple coronary artery stenoses.

The objectives of the study are:

  1. To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical follow-up after multivessel intervention with drug-eluting stents in a prospective patient cohort..
  2. To determine the rate of in-stent restenosis, target lesion and target vessel revascularization (angiographic measures) 6 months in patients with multiple DESs in multiple lesions.
  3. To investigate the clinical and angiographic outcomes after implantation of multiple DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal insufficiency) with known high restenosis and late complication rate.
  4. To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: Intracoronary stent implantation
Taxus stent implantation in patients with multivessel coronary artery disease
Other Names:
  • Taxus Express
  • Taxus Liberte
Experimental: 1
Single-arm study, no placebo or control group
Intervention: Device: Intracoronary stent implantation
Gyöngyösi M, Christ G, Lang I, Kreiner G, Sochor H, Probst P, Neunteufl T, Badr-Eslam R, Winkler S, Nyolczas N, Posa A, Leisch F, Karnik R, Siostrzonek P, Harb S, Heigert M, Zenker G, Benzer W, Bonner G, Kaider A, Glogar D; AUTAX Investigators. 2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study. JACC Cardiovasc Interv. 2009 Aug;2(8):718-27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
441
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • symptomatic coronary multivessel disease
  • possible percutaneous complete coronary revascularization
  • age >18 year
  • significant coronary lesion at least in 2 vessels

Exclusion Criteria:

  • acute myocardial infarction within 48 hours
  • contraindications to clopidogrel, aspirin, heparin and taxol
  • pregnancy or lack of protection against pregnancy or breast-feeding during the study
  • hemorrhagic diathesis
  • platelet count <100.000/ml3
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00738686
AUTAX
Yes
Helmut-Dietmar Glogar, Dept. Cardiology, Medical University of Vienna, Austria
Medical University of Vienna
Not Provided
Principal Investigator: Helmut-Dietmar Glogar, MD FESC Dept. Cardiology, Medical University of Vienna, Vienna, Austria
Medical University of Vienna
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP